Indocyanine Green and Rectosigmoid Endometriosis
- Conditions
- Endometriosis, RectumBowel Endometriosis
- Interventions
- Diagnostic Test: assessment of bowel symptoms before surgeryDiagnostic Test: assessment of rectosigmoid during laparoscopyDiagnostic Test: follow up and assessment of bowel symptoms after surgeryDiagnostic Test: assessment of rectosigmoid perfusion during robot-assisted laparoscopy
- Registration Number
- NCT03532074
- Brief Summary
Indocyanine green is a fluorescent dye used for the intraoperative evaluation of tissue perfusion.
The aim of this study is to evaluate a possible correlation between rectosigmoid vascularization and surgical and clinical data including pre and post-operative bowel symptoms in patients needing surgery for rectosigmoid endometriosis.
- Detailed Description
Patients with symptomatic rectosigmoid endometriosis requiring laparoscopic surgery are included in the study.
Before surgery, bowel symptoms are assessed using validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index).
Indocyanine green is administered through peripheral line. A near-infrared (NIR) camera-head enables real-time direct visualization of bowel perfusion before and after the removal of the rectosigmoid nodule. Rectosigmoid tract perfusion is assessed before and after the removal of the nodule. To estimate the vascularization, a scale with a score between 0 and 4 is used.
After complete removal of rectosigmoid nodule, the post-operative follow-up will be the same as usual after intestinal endometriosis surgery. Postoperative bowel symptoms are evaluated using the same questionnaires.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 40
- Diagnosis of deep endometriosis based on clinical and transvaginal/transabdominal ultrasound examinations and, when necessary, magnetic resonance
- Patients with indication for removal of endometriosic lesions by laparoscopic surgery
- Obtaining Informed Consent
- Known or suspected allergy to iodine
- Previous rectal surgery
- History of active pelvic infection
- Intra-abdominal or pelvic malignancy
- Pelvic radiation therapy
- Hyperthyroidism
- Liver dysfunction
- Serum creatinine > 2.0 mg/dL
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description laparoscopic approach follow up and assessment of bowel symptoms after surgery assessment of bowel symptoms before surgery; assessment of rectosigmoid perfusion using indocyanine green; removal of rectosigmoid endometriosis nodule using a laparoscopic approach; follow up and assessment of bowel symptoms after surgery laparoscopic approach assessment of rectosigmoid during laparoscopy assessment of bowel symptoms before surgery; assessment of rectosigmoid perfusion using indocyanine green; removal of rectosigmoid endometriosis nodule using a laparoscopic approach; follow up and assessment of bowel symptoms after surgery robot-assisted approach assessment of bowel symptoms before surgery assessment of bowel symptoms before surgery; assessment of rectosigmoid perfusion using indocyanine green; removal of rectosigmoid endometriosis nodule using a robot-assisted approach; follow up and assessment of bowel symptoms after surgery robot-assisted approach follow up and assessment of bowel symptoms after surgery assessment of bowel symptoms before surgery; assessment of rectosigmoid perfusion using indocyanine green; removal of rectosigmoid endometriosis nodule using a robot-assisted approach; follow up and assessment of bowel symptoms after surgery laparoscopic approach assessment of bowel symptoms before surgery assessment of bowel symptoms before surgery; assessment of rectosigmoid perfusion using indocyanine green; removal of rectosigmoid endometriosis nodule using a laparoscopic approach; follow up and assessment of bowel symptoms after surgery robot-assisted approach assessment of rectosigmoid perfusion during robot-assisted laparoscopy assessment of bowel symptoms before surgery; assessment of rectosigmoid perfusion using indocyanine green; removal of rectosigmoid endometriosis nodule using a robot-assisted approach; follow up and assessment of bowel symptoms after surgery
- Primary Outcome Measures
Name Time Method correlation between bowel symptoms and rectosigmoid perfusion before the nodule removal intraoperative comparison between bowel symptoms, assessed through validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) and rectosigmoid perfusion, measured before the nodule removal using indocyanine green and a scale from 0 to 4.
- Secondary Outcome Measures
Name Time Method correlation between bowel perfusion after rectal surgery and post-operative complications up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months assessment of rectosigmoid perfusion, through indocyanine green and a scale from 0 to 4, and complications (rectovaginal fistula, dehiscence of anastomotic suture, rectal bleeding, rectosigmoid perforation, rectosigmoid stenosis), using Clavien-Dindo Classification.
correlation between bowel symptoms and rectosigmoid perfusion after the nodule removal up to three months after surgery comparison between rectosigmoid perfusion, measured after the nodule removal using indocyanine green and a scale from 0 to 4, and bowel symptoms, assessed through validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index).
Trial Locations
- Locations (1)
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
🇮🇹Bologna, Italy